Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-21 @ 9:03 AM
Study NCT ID:
NCT02337920
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2015-01-09', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter', 'timeFrame': 'Change - One month, six months and one year after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy']}, 'descriptionModule': {'briefSummary': 'Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing unilateral femoral endarteriectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral femoral endarteriectomy\n\nExclusion Criteria:\n\n* emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy'}, 'identificationModule': {'nctId': 'NCT02337920', 'acronym': 'TEA-NIRS', 'briefTitle': 'Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal', 'orgStudyIdInfo': {'id': 'TEA-NIRS'}}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Georges Daccache, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}